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Thursday, September 24, 2015

台大藥學系友(中華景康) 推動 藥改盟 (藥品政策改革推動聯盟)

各位校友大家好:為了解決台灣民眾用藥安全相關問題、建立完善藥政及藥學教育、保障民眾健康,並促進台灣整體生技醫藥學產業發展,以增進國家競爭力,中華景康藥學基金會毅然推動「藥品政策改革推動聯盟」,相關訊息如下,敬邀各位校友919下午一點一起來新生南路小福華一樓前瞻廳參與此有意義的活動,共襄盛舉!
「藥改盟」的宣言如下台灣藥品在民眾的期許、業者的努力以及政府的推動下,除了施行國際最高規格的品質認證(PIC/S GMP),亦積極推動藥品源頭與運銷管理,近年來用藥品質已能逐步與國際接軌。然而台灣的醫藥環境仍面臨許多困難與挑戰例如,政府投入醫療資源比例嚴重不足且缺乏跨部會的產業輔導升級配套政策與措施,以致影響生技醫藥產業的發展,使民眾無法儘早使用科技新藥,還有不合理的醫藥資源分配及藥價調整,導致嚴重缺藥與斷藥等。有鑑於此,「藥品政策改革推動聯盟」特此集合十五大公協會、八大學院藥學系所,還有產、官、學、研、法人團體,共同號召舉辦專家學者圓桌論壇與聯合研討會,針對藥品安全、普及性、藥事服務、藥業發展及藥學教育等方面提出「藥界白皮書」。我們呼籲,以增進國民健康福祉為首要,秉持王道精神之核心價值,追求可兼顧醫療品質、社會福利、產業發展、全面普及的永續健保制度以及可強化國家競爭力的醫藥政策,期能達成「三贏」、「四藥」。在民眾、政府、生技醫藥產業「三贏」的大前提下,完成「四藥」:「開發生技新醫藥、疑難雜症有解藥、大小病痛不缺藥、身體健康免服藥」。 藥品政策改革推動聯盟成立大會議程時間:2015 9 19 日(星期六  13001630地點:台北市新生南路三段301樓前瞻廳(福華國際文教會館)

      

2015 顧問團名單                                                     2015代表團名單                                                     2015藥改聯盟之組織架構

              
2015 供給品質及藥物安全性                            2015民眾健保藥物可近性及可及性


2015藥事服務及藥學教育

藥改盟 成立 黨總統參選人代表參加 (國民黨: 楊志良/ 民進黨: 陳時中/ 親民黨: 張昭雄)

藥價過低卻推「差額自費」政策 楊志良:衛福部不要「頭殼壞去」Kenzo 2015/09/19 17:18:00你為什麼需要知道這則新聞 藥改盟指出,國內長期面臨藥價過低、藥品供應不足、新藥給付過慢且過低等困境,這些問題的主因就是健保資源不足,支出多、但收入卻很少。 針對國內長期藥價過低、「救命藥比糖果便宜」的困境,藥界學者專家及十多個藥學相關組織今(19日)共同成立「藥品政策改革推動聯盟」,簡稱「藥改盟」,後續將致力於推動藥品白皮書,並解決台灣藥品供應不足、新藥給付過低等問題。對於健保署有意實行「藥品差額自費」措施,與會的前衛生署(現衛福部)署長楊志良強調,千萬不要「頭殼壞去」,執意推動此項政策。藥改盟今天在台北舉行成立誓師大會,有超過200名貴賓與各界代表參加,並邀請各黨總統參選人代表與會,國民黨由前衛生署(現衛生福利部)署長楊志良出席,民進黨由蔡英文醫療小組召集人陳時中代表,親民黨則由副主席張昭雄參加。藥改盟指出,國內長期面臨藥價過低、藥品供應不足、新藥給付過慢且過低等困境,這些問題的主因就是健保資源不足,支出多、但收入卻很少。因此,藥改盟期盼推動政府預算改革,讓政府對健保的支出增加。藥改盟發言人吳力人表示,台灣健保制度在全球名列前茅,但資源明顯不足,因此藥改盟首要推動政府預算改革,期盼政府增加在健保的支出。 聯合報導,藥改盟進一步指出,依目前台灣醫療費用僅占國內生產毛額(GDP)為6.6%,相較美國的16%、日本10.3%、韓國7.8%等,台灣均偏低,顯示醫療費用投入不足,政府應提高公務預算。西藥代理商業同業公會榮譽顧問王文德也說,過去政府為節省藥價支出,以調降藥價為主要手段,醫院也為了賺錢,與廠商議價壓錢,靠藥價差營利。這樣的現象,導致部分藥廠因虧損而停產藥品,造成國內出現缺藥、斷藥等問題,他認為政府應更重視病人利益,而非只在藥價上斤斤計較。蘋果報導,與會的前衛生署署長楊志良針對藥價過低的現象提出幾點建議,首先,他呼籲健保署不要再進行藥價調查,應觀察三項指標,一是沒有藥品推銷員於診間向醫師推銷藥物,其次是當醫師打高爾夫球時,沒有藥商願意幫醫師付錢,最後是醫師出國進修時,沒有藥商願意幫忙付錢,此三項指標已凸顯藥品價格給付確實過低。楊志良強調,衛福部不要「頭殼壞去」,萬萬不可推動藥品差價負擔政策,若繼續推動等於政府公開承認國內通過國際醫藥品稽查協約組織(PIC/S)的GMP藥廠全是玩假的,證實學名藥相較原廠藥品質確實有差,他也相信臨床醫師親身用藥確實有差的感受,因此建議衛福部請藥界進入國內藥廠,改革藥廠藥品製成,提升藥品品質。

美時幫太景代工/ 懷特、中天、寶齡產能放大

利多到 藥廠大擴產 20150923 04:10 記者杜蕙蓉/台北報導 國產生技新藥列入醫院評鑑指標,可望在2年內取得藥證,並符合生技發展新藥條例國內廠商則已備足銀彈準備「行軍」!懷特、中天、寶齡產能放大外,F-太景將由美時代工,順藥則洽談代工廠中,預計2016該新藥公司營運將高歌。初步統計,今年5月止,目前共有84家公司、202項研發中新藥,通過「生技新藥產業發展條例」之「生技新藥」資格審定,其中懷特的懷特血寶,中天的化療漾和賀必容都已上市銷售;寶齡和太景正申請健保價。另外,申請藥證的智擎和順藥可望是第一波生技新藥列入醫院評鑑指標的最受惠公司。至於第二波的藥廠,則包括中裕、浩鼎和合一等,藥華用於治療真性紅血球增生症(PV)的P1101,雖然有機會在明年申請歐盟和美國藥證,但因該藥尚未申請生技新藥產業發展條例,隨著制度的修改,不排除也跟進申請。據了解,為了儘速取得門票,趕在國內上市銷售,懷特斥資數億元興建台灣首座符合PIC/S 與美國FDAGMP規範的「無菌植物新藥精製廠」,除了放大產能外,總經理鄭建新表示,近年也積極調整製程,降低生產成本。中天集團董事長路孔明表示,中天已規畫投資十餘億元在龍潭興建新廠,該廠年產能為100萬瓶,是現有產能12萬瓶的8倍,預估2016年第3季投產。合一則決斥資5億元在屏東興建南州廠,初估軟膏廠初期年產規模約2千萬條 ,預計2015年底完工。順藥總經理黃文英表示,該公司開發的長效止痛新藥LT1001,目前積極尋求合作的代工廠商和通路中,且將對外授權。(工商時報)

醫學中心評鑑藥加分 需採購國產新藥與醫材 !!!

破天荒醫學中心評鑑 須納國產新藥 20150923 04:10 記者杜蕙蓉/台北報導 破天荒!衛福部藥事司醫院評鑑委員會昨(22)日通過,採購國產生技新藥將列入醫學中心評鑑指標,此舉不僅扭轉醫學中心好用國外藥廠風氣,也讓取得適用生技發展新藥條例的新藥、醫療器材廠,終於有機會在台「大展鴻圖」。

明年是醫學中心評鑑年 明年剛好是醫學中心的大評鑑年,預期將躋身醫學中心的醫院將大舉採購國產生技新藥,已獲得藥證的懷特、中天,申請健保價的太景和寶齡,申請藥證中的智擎和順天,都成為大贏家。

新藥和醫材進駐醫院鬆綁 生醫業界認為,這是政府對於台灣研發新藥與新醫材,將給予鼓勵性的健保核價機制,以利開創國際市場後,再次對生技新藥和醫材的進駐醫院的大鬆綁,被視為是政府對生技產業最大德政。目前國內共有19家醫學中心,法令規定是採一退一出制,也就是有一家被刷下來,另一家才能擠進去,因此,四年一次的大評鑑是醫院界盛事。目前醫學中心共有五項任務指標基準,每項指標各佔20分,其中,針對醫療服務、公益責任、全人照護和參與國際衛生活動,一般認為各家醫院的水準相差不大,但第四項的創新研發提升醫療品質其中的4.1.4項目-促進國內生技醫藥產業發展,提升醫療健康水準,被視為評鑑的決勝點。

勢必大舉採購國產新藥 4.1.4項目,評分標準此次已修正為過去4年採購國產符合生技新藥發展條例的新藥與醫療器材;亦即為了拿到第四項指標的20分,醫學中心必然要採購國產生技新藥和醫療器材,讓符合生技新藥發展條例的廠商大大受惠。生醫業界指出,鄰近韓國、日本、大陸都對國產藥祭出保護機制,唯獨台灣是放任國際藥廠的予取予求,以致於會發生台灣學名藥廠在國內健保的用量占比75%,但藥價占比只有23%,國內健保資源與市場資源一直都是被國際壟斷。其實,國內藥廠的開發和生產水準有目共睹,不僅是亞洲第一家PIC/S GMP會員國,開發的學名藥也已經進軍9個先進國家,生技新藥也都符合國際ICH法規,有專利、有創新,也有嚴謹的人體臨床,因此,國產生技新藥列入醫院評鑑指標,亦將讓國內開發的生技新藥和醫材能夠大規模進軍國內醫院。(工商時報)

安克 布局高毛利高階醫材新興產業: 自動腫瘤輪廓特徵量化分析 !

安克生醫如虎添翼 亮紅燈 2015-09-22 14:36:37 聯合晚報 記者徐睦鈞/台北報導上櫃股安克生醫(4188)今宣布,該公司甲狀腺超音波電腦輔助偵測診斷系統,近來不僅逐步被各大醫院、健檢中心採用,經過多年布局,今年已陸續完成台灣、美國的完整專利保護,並再獲捷報,獲得中國專利,產品獨創性備受肯定。安克股價收盤亮燈漲停。安克生醫總經理陳正剛博士表示,甲狀腺腫瘤是常見疾病,大多的良性腫瘤在無法確診下接受穿刺檢查。安克成功研發上市的電腦輔助偵測診斷系統,運用創新的影像處理技術,可將現行的黑白超音波影像,量化甲狀腺腫瘤特徵,並將影像彩色視覺化,以協助醫師判讀,即時提供醫師診斷報告,病人也可輕鬆、安全、迅速、準確受檢,逐步降低良性腫瘤不必要的侵入性穿刺檢查。在台灣、美國等地申請的三項專利內容,分別為自動定義腫瘤範圍擷取輪廓、第二項則是量化分析腫瘤的特徵、最後一項專利則是辨別腫瘤良惡性的方法。這些專利都是腫瘤影像辨識分析的重要技術,除了用於已商品化的甲狀腺超音波電腦輔助偵測診斷系統,更可應用於其他影像及癌症種類。目前於台灣、新加坡、美國都已順利取得三項專利保護。陳正剛表示,這些已通過的專利保護至少在未來的15年內,保護安克產品的競爭性,在國外授權談判上亦更有籌碼。董事長李成家也表示,安克的高階醫材,是高附加價值、高毛利的新興產業,隨著全球專利佈局日趨完整,對於產品推廣將發揮如虎添翼的效果。

新英格蘭期刊: 台灣醫療服務滿意度 全球第三(倒數)!

藥比糖便宜 藥改盟推白皮書 2015-09-19 16:24:06 聯合報 記者鄧桂芬╱即時報導台灣藥價比糖果便宜,導致廠商停產或不進藥,進而造成缺藥等問題,影響國人用藥權益。西藥代理商業同業公會榮譽顧問王文德於「藥品政策改革推動聯盟」成立會上表示,產官學界將提出以病人為中心的「藥物(品)白皮書」,供政府施政參考,改革國內用藥環境問題,最快今年底完成。去年底「新英格蘭期刊」公布調查,全球29個國家中,台灣民眾對醫療服務的滿意度排名倒數第三,幾乎吊車尾。王文德表示,過去政府為節省藥價支出,以調降藥價為主要手段;醫院也為了賺錢,與廠商議價壓錢,靠藥價差營利,低價藥的品質就會有差。另外,部分藥廠因虧損而停產藥品,也可能造成國內出現缺藥、斷藥等問題。他認為,政府應更重視病人利益,而非只在藥價上斤斤計較。藥改盟發言人吳力人也說,依目前台灣醫療費用僅占國內生產毛額(GDP)為6.6%,相較美國的16%、日本10.3%、韓國7.8%等,台灣均偏低,顯示醫療費用投入不足,政府應提高公務預算。前衛生署長楊志良表示,健保署不用再進行藥價調查,事實上,觀察醫師診間有無藥品推銷員,或是醫師打高爾夫球、出國進修時,有無藥商願意幫忙付錢,若都沒有,可見藥價給付確實過低。楊志良也批評,衛生福利部日前公布的「藥品差額負擔試辦計畫」,根本是本末倒置、頭殼壞掉,全世界沒有其他國家這樣搞,若繼續推動等於是政府公開承認國內的PIC/S MP藥廠全是玩假的,證實學名藥相較原廠藥的品質確實有差異。他建議,衛福部應請藥界進入國內藥廠,改革藥廠藥品製成、提升品質。

穆拉德 解除競業 (鍾祥鳳/ 神守健康 )

穆拉德:公告本公司董事會決議解除經理人之競業禁止限制 鉅亨網新聞中心  2015-09-18 19:17:29  第二條 第211.董事會決議日:104/09/18 2.許可從事競業行為之經理人姓名及職稱:鍾祥鳳總經理3.許可從事競業行為之項目:鍾祥鳳總經理:神守健康事業股份有限公司董事長4.許可從事競業行為之期間:為任職本公司經理人期間。5.決議情形(請依公司法第32條說明表決結果):除董事兼總經理鍾祥鳳先生依公司法第206條規定表決權行使之迴避外,經其餘出席董事決議通過在無損及本公司利益之前提下,同意上開競業行為。6.所許可之競業行為如屬大陸地區事業之營業者,經理人姓名及職稱(非屬大陸地區事業之營業者,以下請輸〝不適用〞):不適用。7.所擔任該大陸地區事業之公司名稱及職務:不適用。8.所擔任該大陸地區事業地址:不適用。9.所擔任該大陸地區事業營業項目:不適用。10.對本公司財務業務之影響程度:不適用。11.經理人如有對該大陸地區事業從事投資者,其投資金額及持股比例:無。12.其他應敘明事項:無。

匯特 1000萬投資 樂活醫務管理 (加速人工玻璃體臨床試驗)

匯特:公告本公司取得樂活醫務管理股份有限公司股權 鉅亨網/鉅亨網新聞中心-20150923 上午08:00 第三十四條 第171.標的物之名稱及性質(屬特別股者,並應標明特別股約定發行條件,如股息率等):樂活醫務管理股份有限公司普通股。2.事實發生日:104/9/22~104/9/223.交易數量、每單位價格及交易總金額:(1)交易單位數量:1,000,000股。(2)每單位價格:10元。(3)交易總金額:10,000,0004.交易相對人及其與公司之關係(交易相對人如屬自然人,且非公司之關係人者,得免揭露其姓名):不適用。5.交易相對人為關係人者,並應公告選定關係人為交易對象之原因及前次移轉之所有人、前次移轉之所有人與公司及交易相對人間相互之關係、前次移轉日期及移轉金額:不適用。6.交易標的最近五年內所有權人曾為公司之關係人者,尚應公告關係人之取得及處分日期、價格及交易當時與公司之關係:不適用。7.本次係處分債權之相關事項(含處分之債權附隨擔保品種類、處分債權如有屬對關係人債權者尚需公告關係人名稱及本次處分該關係人之債權帳面金額:不適用。8.處分利益(或損失)(取得有價證券者不適用)(原遞延者應列表說明認列情形):不適用。9.交付或付款條件(含付款期間及金額)、契約限制條款及其他重要約定事項:(1)交付或付款條件:預定於10409月份完成付款。(2)契約限制條款:無。(3)其他重要約定事項:無。10.本次交易之決定方式、價格決定之參考依據及決策單位:(1)本次交易之決定方式及決策單位:依本公司董事會決議辦理。(2)價格決定之參考依據:經參酌交易標的之每股淨值後與交易相對人議定之11.迄目前為止,累積持有本交易證券(含本次交易)之數量、金額、持股比例及權利受限情形(如質押情形):(1)累積持有本交易證券之數量:1,000,000股。(2)累積持有本交易證券之金額:10,000,000元。(3)累積持有本交易證券之持股比例:14.30%(4)權利受限情形:無。12.迄目前為止,依「公開發行公司取得或處分資產處理準則」第三條所列之有價證券投資(含本次交易)占公司最近期財務報表中總資產及歸屬於母公司業主之權益之比例暨最近期財務報表中營運資金數額(註二):(1)1040630日總資產比例:3.14%(2)1040630日股東權益比例:3.20%(3)1040630日營運資金數額:248,268,591元。13.經紀人及經紀費用:不適用。14.取得或處分之具體目的或用途:(1)透過投資標的物之眼科醫療平台,轉介需施作人工玻璃體手術之病患參與人體臨床試驗,使人工玻璃體產品能盡早完成人體臨床試驗並上市。(2)預期短期內將獲利。15.本次交易表示異議董事之意見:無。16.本次交易為關係人交易:17.董事會通過日期:不適用。18.監察人承認日期:不適用。19.本次交易會計師出具非合理性意見:20.其他敘明事項:無。

太景: 健保 新藥定義 不符國際現況 !!!

太景新藥 撤回健保核價 2015-09-22 00:59:44 經濟日報 記者黃文奇/台北報導F*太景(4157)昨(21)日表示,旗下抗感染新藥太捷信已獲得藥品許可證,在取得健保核價之前,將以自費方式於全台醫療院所開賣,撤回健保藥價申請案。太景說,有鑒於抗感染新藥太捷信在台第一上市之健保價,攸關進軍國際市場之定價策略與利潤空間,太景將於衛生福利部完成鼓勵性核價機制相關條文修訂後,再度提出太捷信之健保藥價申請,以取得政策性之優惠健保價,擴大外銷市場之價值。太景昨日股價因此利多激勵,上漲2.55元,收28.45。據悉,政府為鼓勵在我國進行研發並以台灣為第一上市國之新成分新藥,行政院於去年4月通過新增「全民健康保險藥物給付項目及支付標準」第17條之1:符合條件在台灣第一個上市的新藥,可以依據從參考市場交易價、參考成本計算法,或者是參考治療類似品之十國藥價中,擇一核價。不過,此規定的關鍵在於「新藥」必須符合「臨床療效有明顯改善」或「治療特定疾病」的條件。太景指出,此一定義顯然不符國際藥品研發市場的現況。

Daraprim (pyrimethamine) 大漲50倍的奧秘!!!

1顆「藥價」2希拉蕊籲降 2015-09-23 〔編譯李信漢/綜合報導〕美國圖靈藥廠(Turing Pharmaceuticals )今年8月才取得弓蟲病用藥達拉匹林(Daraprim)的製藥權,本月就宣布將該藥售價從單顆13.5美元(約台幣442元),調漲到每顆750美元(約台幣25000元),足足調漲逾50倍。此舉引起醫藥界強烈抗議,連民主黨總統參選人希拉蕊也宣示將採取行動,打擊調漲特定用藥的藥商。 飆漲50 醫界抗議 達拉匹林是於1940年代研發,用以治療弓蟲病(toxoplasmosis)感染的用藥。弓蟲病為一種寄生蟲疾病,現已不常見,然而,如果是經由母親垂直感染給嬰兒,或是因感染愛滋或其他癌症導致免疫系統受損的成人染患弓蟲病,就有可能喪命。 對於圖靈藥廠大幅調漲藥價,「美國傳染病學會」(Infectious Diseases Society of AmericaIDSA)等多個醫學團體9月初發表公開信,要求圖靈藥廠重新考慮。公開信中指陳,達拉匹林不合理的藥價會對真正有用藥需求的弱勢族群造成傷害,並讓醫療保險體系難以維持。 在龐大批評聲浪下,曾任避險基金經理人的圖靈藥廠執行長史克瑞里(Martin Shkreli)本週終於出面辯解,宣稱藥廠必須要讓達拉匹林能夠獲利,因為之前的公司幾乎都放棄了達拉匹林;他強調,調漲的藥價將用來研發新版本的達拉匹林,「我們是數十年來第一家真正專注在這種藥物的藥廠,而這種研究是十分花錢的。」他還說,如果你買不起達拉匹林,他們可以免費贈送。 根據英國廣播公司(BBC)報導,達拉匹林每顆製藥成本才1美元,但史克瑞里稱,這個成本未包含像是行銷和配送等成本。稍早史克瑞里還曾在社群網站「推特」(Twitter)上嘲笑那些質疑圖靈藥廠決策的人,指稱一名記者為「傻蛋」。 民主黨總統參選人希拉蕊在紐約時報報導該項藥價調整新聞後,即透過推特發文說,如此拉高特定藥物售價,「令人憤怒」。她之後在阿肯色州的競選場合上承諾,未來將以鼓勵研發、採用學名藥與利用政府購買力當作談判籌碼的方式,來打擊不合理暴漲的藥價。希拉蕊的談話讓21日華爾街生物科技公司的股價大幅下跌Drug Company Reverses Course on Controversial Price HikeThe price of Daraprim had gone from $13.50 a tablet to $750 A pharmaceuticals company that raised the price of a drug 5,500% practically overnight says it will now lower its price following intense backlash. Turing Pharmaceuticals founder Martin Shkreli confirmed the price cut to NBC News on Tuesday but did not say how much the company would reduce the cost of Daraprim. Early this week, Turing's decision to raise the price of Daraprim from $13.50 a tablet to $750 was the subject of a New York Times story. The drug, which is generically known as pyrimethamine and was acquired by the company acquired in August, is used to treat a serious parasitic infection called toxoplasmosis, which can be life-threatening for those with compromised immune systems. It's also been used to treat malaria. Shkreli said the new price will allow the company to break even or make a "small profit" on the drug.

Drug Goes From $13.50 a Tablet to $750, Overnight  By ANDREW POLLACKSEPT. 20, 2015 Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection. The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars."What is it that they are doing differently that has led to this dramatic increase?" said Dr. Judith Aberg, the chief of the division of infectious diseases at the Icahn School of Medicine at Mount Sinai. She said the price increase could force hospitals to use "alternative therapies that may not have the same efficacy." Turing's price increase is not an isolated example. While most of the attention on pharmaceutical prices has been on new drugs for diseases like cancer, hepatitis C and high cholesterol, there is also growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment. Martin Shkreli is the founder and chief executive of Turing Pharmaceuticals, which raised the price of the drug Daraprim to $750 a tablet from $13.50.  Although some price increases have been caused by shortages, others have resulted from a business strategy of buying old neglected drugs and turning them into high-priced "specialty drugs."Cycloserine, a drug used to treat dangerous multidrug-resistant tuberculosis, was just increased in price to $10,800 for 30 pills from $500 after its acquisition by Rodelis Therapeutics. Scott Spencer, general manager of Rodelis, said the company needed to invest to make sure the supply of the drug remained reliable. He said the company provided the drug free to certain needy patients. In August, two members of Congress investigating generic drug price increases wrote to Valeant Pharmaceuticals after that company acquired two heart drugs, Isuprel and Nitropress, from Marathon Pharmaceuticals and promptly raised their prices by 525 percent and 212 percent respectively. Marathon had acquired the drugs from another company in 2013 and had quintupled their prices, according to the lawmakers, Senator Bernie Sanders, the Vermont independent who is seeking the Democratic nomination for president, and Representative Elijah E. Cummings, Democrat of Maryland.Doxycycline, an antibiotic, went from $20 a bottle in October 2013 to $1,849 by April 2014, according to the two lawmakers.The Infectious Diseases Society of America and the HIV Medicine Association sent a joint letter to Turing earlier this month calling the price increase for Daraprim "unjustifiable for the medically vulnerable patient population" and "unsustainable for the health care system." An organization representing the directors of state AIDS programs has also been looking into the price increase, according to doctors and patient advocates.Daraprim, known generically as pyrimethamine, is used mainly to treat toxoplasmosis, a parasite infection that can cause serious or even life-threatening problems for babies born to women who become infected during pregnancy, and also for people with compromised immune systems, like AIDS patients and certain cancer patients. Martin Shkreli, the founder and chief executive of Turing, said that the drug is so rarely used that the impact on the health system would be minuscule and that Turing would use the money it earns to develop better treatments for toxoplasmosis, with fewer side effects."This isn't the greedy drug company trying to gouge patients, it is us trying to stay in business," Mr. Shkreli said. He said that many patients use the drug for far less than a year and that the price was now more in line with those of other drugs for rare diseases."This is still one of the smallest pharmaceutical products in the world," he said. "It really doesn't make sense to get any criticism for this."This is not the first time the 32-year-old Mr. Shkreli, who has a reputation for both brilliance and brashness, has been the center of controversy. He started MSMB Capital, a hedge fund company, in his 20s and drew attention for urging the Food and Drug Administration not to approve certain drugs made by companies whose stock he was shorting.In 2011, Mr. Shkreli started Retrophin, which also acquired old neglected drugs and sharply raised their prices. Retrophin's board fired Mr. Shkreli a year ago. Last month, it filed a complaint in Federal District Court in Manhattan, accusing him of using Retrophin as a personal piggy bank to pay back angry investors in his hedge fund.Mr. Shkreli has denied the accusations. He has filed for arbitration against his old company, which he says owes him at least $25 million in severance. "They are sort of concocting this wild and crazy and unlikely story to swindle me out of the money," he said. Martin Shkreli, the chief executive of Turing Pharmaceuticals, explains the increase in drug prices in a CNBC interview. By CNBC on Publish Date September 21, 2015. Photo by CNBC. Daraprim, which is also used to treat malaria, was approved by the F.D.A. in 1953 and has long been made by GlaxoSmithKline. Glaxo sold United States marketing rights to CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Mr. Shkreli and other investors in its first round of financing. Daraprim cost only about $1 a tablet several years ago, but the drug's price rose sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, sales of the drug jumped to $6.3 million in 2011 from $667,000 in 2010, even as prescriptions held steady at about 12,700. In 2014, after further price increases, sales were $9.9 million, as the number of prescriptions shrank to 8,821. The figures do not include inpatient use in hospitals. Turing's price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price. Some doctors questioned Turing's claim that there was a need for better drugs, saying the side effects, while potentially serious, could be managed. "I certainly don't think this is one of those diseases where we have been clamoring for better therapies," said Dr. Wendy Armstrong, professor of infectious diseases at Emory University in Atlanta. With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim's distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing. The switch from drugstores to controlled distribution was made in June by Impax, not by Turing. Still, controlled distribution was a strategy Mr. Shkreli talked about at his previous company as a way to thwart generics. Some hospitals say they now have trouble getting the drug. "We've not had access to the drug for a few months," said Dr. Armstrong, who also works at Grady Memorial Hospital, a huge public treatment center in Atlanta that serves many low-income patients.But Dr. Rima McLeod, medical director of the toxoplasmosis center at the University of Chicago, said that Turing had been good about delivering drugs quickly to patients, sometimes without charge."They have jumped every time I've called," she said. The situation, she added, "seems workable" despite the price increase.Daraprim is the standard first treatment for toxoplasmosis, in combination with an antibiotic called sulfadiazine. There are alternative treatments, but there is less data supporting their efficacy.Dr. Aberg of Mount Sinai said some hospitals will now find Daraprim too expensive to keep in stock, possibly resulting in treatment delays. She said that Mount Sinai was continuing to use the drug, but each use now required a special review."This seems to be all profit-driven for somebody," Dr. Aberg said, "and I just think it's a very dangerous process."

兆豐 生命基金 黃耀德: NBI指數(那斯達克生技類)報酬率10.7%(十年新高)

生醫基金 四利多護體 2015-09-23 07:17:28 經濟日報 記者王奐敏/台北報導 分享聯準會9月不升息,全球股市隨之震盪,今年來全球股市修正約3%,醫療保健指數逆勢漲近6%法人分析,在政策做多、併購風、上市熱、創新動能等四大利多加持下,投資人不妨逢低進場布局生醫基金 政策方面,保德信全球醫療生化基金經理人江宜虔表示,今年6月,美國最高法院裁定,歐巴馬健保法案(Obama Care)的聯邦補助適用全美國,美國醫療保險業者營運規模擴大,對藥品的議價能力順勢提高,醫療保險業者可選擇藥價較合理的廠商合作,激勵醫療服務類股今年走勢。江宜虔指出,今年以來醫療產業在MSCI十大類產業中最為抗跌,預估盈餘成長率維持在三成以上,是全球股市的二倍;隨藥品核准件數攀升,研發結果不斷突破,以及併購題材發酵,生醫產業後市可期。江宜虔分析,醫療產業中長期有三大驅動力,包括人口高齡化趨勢、新興市場國家對醫療產業的需求隨所得提高而增加,以及生技、製藥、醫療器材等技術不斷創新,基本面優異。兆豐國際生命科學基金經理人黃耀德表示,那斯達克生技指數(NBI)的股東權益報酬率達10.7%,創下十年新高,表示生技產業獲利強勁,能量仍持續攀升。生技股獲利能力來自強大的創新與研發,不僅是價格。藥物市場的穩定與增加創新能量反而對生技業是長久性的利多,投資人可正面看待。德盛全球生技大壩基金經理人傅子平表示,儘管美國民主黨總統候選人希拉蕊表示將打擊特殊用藥的藥商哄抬藥品行為,引發NBI指數震盪。不過,回歸產業基本面來看,並未出現重大變化。不僅新藥審核佳音頻傳,在專利到期高峰與低利環境下,併購熱潮延燒,可望提升產業綜效與長線發展,罕見疾病、中樞神經、病毒感染與癌症,具併購題材公司將持續成為產業亮點。